European Commission Approves Roche’s Evrysdi Tablet Form, New Room-Temperature Option For Spinal Muscular Atrophy

Roche has received European Commission approval for a label extension of Evrysdi® (risdiplam), introducing a new 5mg tablet formulation for spinal muscular atrophy (SMA). This room-temperature stable tablet, which can be swallowed whole or dissolved in water, does not require refrigeration and can be taken with or without food, enhancing ease of use for patients and caregivers.

“The new Evrysdi tablet with its flexible administration represents progress toward more versatile SMA disease management. With over 18,000 people treated to date, Evrysdi’s proven efficacy, safety and convenience has significantly improved the course of disease for people living with SMA," said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development, Roche. 

Evrysdi works by increasing and maintaining SMN protein levels throughout the central nervous system and peripheral tissues. With this new tablet form, the treatment becomes even more convenient and portable, especially for individuals over two years of age and weighing at least 20kg who can swallow tablets without feeding assistance.

“We welcome the development of new treatment formulations that have the potential to further simplify disease management and care for people living with SMA. This is a disease requiring daily management, and it is paramount that people living with SMA, and those who care for them, are given options to optimise treatment administration,” Nicole Gusset, Chief Executive Officer, SMA Europe, commented.

Researchers verified the bioequivalence of the tablet with an original oral solution, followed by the NCT04718181 study. Both formulations will continue to be sold, so patients have the chance to pick one that suits their habits or requirements.